CAPA Featured Articles

  1. 3 Problems To Avoid When Establishing A Quality System 10/23/2012

    For some products on the market, quality is a luxury or an option. However, when your product is under the FDA umbrella, quality is required by law if you want to do business in the United States. In the pharmaceutical industry, the customers we serve have very precise expectations when it comes to product quality — nothing but the best, with the highest standards of production and manufacturing. Because the end product affects people's lives, pharma companies aren’t afraid to pay whatever it takes to achieve quality.

  2. What Does Vertex Look For When Selecting A CRO? 5/24/2012

    Peter A. DiBiaso is the head of clinical business operations for Vertex Pharmaceuticals and responsible for the leadership of clinical business operations in support of Vertex’s global development portfolio. By Rob Wright, Chief Editor, Life Science Leader magazine

  3. 7 Ways To Prepare For An Inspection 5/16/2012

    In the pharmaceutical, biopharmaceutical, and medical device industries, regulatory compliance is a major responsibility and a common source of anxiety. However, there’s no need to stress over the possibility of an FDA inspection — if you take the appropriate steps to prepare. This was the guidance Rosario Quintero-Vives, regulatory and compliance specialist with RQV Consulting, offered to a packed room of INTERPHEX 2012 attendees, on the potential problem areas to address before the FDA comes to call. She went on to highlight seven actions you can take to help make the inevitable FDA inspection go more smoothly.  By Lori Clapper, Editor

  4. Setting Realistic Timetables For Deviations, Complaints, And CAPAs

    Priorities are important to have in any environment, and regulated environments are no exception. When you are planning your quality system, you must keep your priorities top of mind; otherwise, regulatory agency visits could end in trouble. When you establish timetables to address any deviation of procedure, product complaints, or even CAPAs, you have to plan realistically — or you will put yourself and your business in a very tight position. Prioritization is critical because it can be difficult to remediate too many observations at once while you are still in production. By Rosario Quintero-Vives, Senior Regulatory and Compliance Specialist, RQV Consulting